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Not recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT06029894

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Citicoline Supplement

Placebo

Study Details

Brief summary:

The purpose of this research is to learn whether a dietary citicoline supplement will impact sleep and cognition. Cognitive disorders include such things as memory disorders and mild cognitive impairment. The investigators are studying persons with mild cognitive impairment (MCI). For this population, the team will assess whether citicoline also impacts biomarkers, a marker of the patient's biological state, in their body.

The investigators are interested in learning more about a dietary supplement called citicoline and how it helps sleep, cognition, and markers of Alzheimer's. Previous studies have evaluated this dietary supplement and shown that citicoline may impact cognitive decline. The investigator would like to evaluate if citicoline will also impact sleep and markers of Alzheimer's. This dietary supplement has been assessed in older adults and found to be well tolerated. Citicoline has been used safely in cognitive impairment populations at the same dosage.

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Study ID

NCT06029894

Start date

Dec 15, 2023

Status verified date

Jan, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 60 years or older
  • Diagnosis of Mild Cognitive Impairment (MCI)
  • Pittsburgh Sleep Quality Index total score >5 or Epworth Sleepiness Scale score of ≥ 10
  • Read and understand English
  • Have Internet and email access

Exclusion Criteria:

  • No telephone access
  • Must not be taking any medication known to affect rapid eye movement (REM) sleep (or sleep architecture in general)
  • Use of choline supplements.
  • Epilepsy or head trauma resulting in unconsciousness in the past two years
  • Known allergic reactions to components of Citicoline
  • Presence of chronic obstructive pulmonary disease, asthma, severe cardiac insufficiency (congestive heart failure, myocardial infarction), type I diabetes, vitamin B12 or folic acid deficiency, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure, severe/unstable psychiatric disorders, moderate to severe obstructive sleep apnea, restless legs syndrome or periodic limb movement disorder
  • History of alcohol dependence and drug abuse
  • Night shift workers or those in situations where they regularly experience jet lag or have irregular work schedules

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Participants with MCI will receive dietary citicoline supplements.

placebo comparator: Placebo

Participants with MCI will receive a placebo supplement.

Interventions

Citicoline Supplement

Participants with MCI will receive dietary citicoline supplements. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months. Participants will undergo a blood draw of approximately 20 ml at baseline and at follow-up.

Placebo

Participants with MCI will receive a placebo supplement. Subjective sleep measures will be measured via the Pittsburgh Sleep Quality Index (for measurement of sleep quality) and Epworth Sleepiness Scale (for measurement of sleepiness). Cognition will be measured by Rey Auditory Verbal Learning Test (RAVLT), Trail Making Test (TMT) Parts A \& B, and the Montreal Cognitive Assessment (MOCA). Participants will complete all questionnaires at baseline and at follow-up at 3 months. Participants will undergo a blood draw of approximately 20 ml at baseline and at follow-up.

Primary outcome measure

  • Change in the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and 3 months ]
  • Change in the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline and 3 months ]
  • Change in percentage of the rapid eye movement (REM) sleep [ Time Frame: Baseline and 3 months ]
  • Change in sleep duration [ Time Frame: Baseline and 3 months ]
  • Change in plasma choline levels [ Time Frame: Baseline and 3 months ]
  • Change in beta-amyloid 42 levels [ Time Frame: Baseline and 3 months ]
  • Change in tau and phospho-tau levels [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Victoria Pak, PhD, MS, MTR

470-296-0081victoria.m.pak@emory.edu

Locations

Emory University School of Nursing

Recruiting

Atlanta, Georgia, United States, 30322

Goizueta Alzheimer's Disease Research Center

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Jan 22, 2025

Last verified

Jan, 2025

Keywords

  • Dementia
  • Citicoline supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Emory University on 2025-01-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.